The sheer number of potential strategies for improving the solubility of a compound – which include various methods of particle size reduction, solid dispersions, salt formation, lipid formulations, inclusion complexes, nanocrystals, and a wide variety of other technologies – can overwhelm many developers, leaving them unsure how to choose a path forward.

At the same time, companies are under significant pressure to advance development programs in order to move to the next stage of funding as quickly as possible. In their rush to advance their molecules into the clinic, some biopharma companies ignore questions about solubility until later in development when the issue becomes unavoidable. Many other companies are willing to roll the dice and pick a solubility enhancement technology based on a low initial cost or because they think that the process would be simple to scale up or a trusted consultant advises that the technology works for most molecules.

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